# K241226: Fixtemp® C&B 4:1

- Pathway: 510(k) (Special)
- Applicant: Dreve Denatmid GmbH
- Decided: May 31, 2024 after 29 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020092 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171729: Fixtemp C&B, Dreve Dentamid GmbH (2017) Summary page 5.

## Indications for use
Fixtemp@ C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.

Source page: https://510kreport.com/device/K241226
Methodology: https://510kreport.com/methodology